Status:
TERMINATED
Safety and Effectiveness Study of the HERCULINK 14 Stent to Treat Renal Artery Disease
Lead Sponsor:
Abbott Medical Devices
Conditions:
Renal Artery Obstruction
Eligibility:
All Genders
18+ years
Phase:
PHASE3
Brief Summary
The purpose of this study is to evaluate the safety and effectiveness of the RX HERCULINK 14 Peripheral Stent System in treating atherosclerotic renal artery stenosis.
Detailed Description
A prospective, non-randomized, multi-center, single-arm clinical trial to evaluate the safety and efficacy of the RX HERCULINK™ 14 Peripheral Stent System in the treatment of suboptimal post- procedur...
Eligibility Criteria
Inclusion
- Clinical diagnosis of renal artery atherosclerosis; candidate for renal artery angioplasty and stenting; blood pressure \>160/90
Exclusion
- Totally occluded renal artery on the opposite side; only one functioning kidney; target lesion is in a transplanted kidney; renal insufficiency
Key Trial Info
Start Date :
July 1 2000
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 1 2004
Estimated Enrollment :
167 Patients enrolled
Trial Details
Trial ID
NCT00180544
Start Date
July 1 2000
End Date
August 1 2004
Last Update
July 28 2008
Active Locations (1)
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1
Alton Ochsner Medical Foundation
New Orleans, Louisiana, United States, 70121